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WCBP 2016: Round Table Notes
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Below you will find links to notes taken during the Round Table session at WCBP 2016.  

If you have questions regarding the links, please contact Project Coordinator Anna Lingel (



Table 1 - Comparability Issues in Biological Products in Regards to Changes in
Critical Raw Materials, Process and Assay
Click Here 
Table 2 - Control and Characterization of Biotherapeutic Glycosylation and Other PTMs Click Here
Table 3 - Implications of Product Specific Monographs for Biotherapeutic Products Click Here
Table 4 - Forced Degradation Studies: Best Practices & Strategies Click Here 
Table 5 - Potency Assays: Cell Based vs. Non Cell Based Formats Click Here
Table 6 - The Holy Grail: Global Specifications Click Here
Table 7 - Trends in Regulatory Inspections and Best Practices Click Here 
Table 8 - Accelerated Development (Global Considerations) Click Here
Table 9 -  Characterization of Complex Vaccines Click Here
Table 10 - Accelerating Late-Stage Development Not Available 
Table 11 - CMC Challenges for Breakthrough Programs Click Here
Table 12 - Biosimilars Click Here
Table 13 - Biologics Process Control Click Here 
Table 14 - Setting Phase Appropriate Specifications  Click Here
Table 15 - Identity Testing to Support Lot Release Click Here
Table 16 - Raw Material Testing - Enough is Enough! Or is it? Click Here 
Table 17 - Control and Characterization of Host Cell Proteins and Residual DNA Not Available 
Table 18 - Low Endotoxin Recovery Click Here
Table 19 - Lessons Learned from QbD Click Here
Table 20 - Blood Analytics Not Available 
Table 21 - Structure/Function Characterization Click Here 
Table 22 - Developing Bi-specifics Click Here
Table 23 - Biopharmaceutical Knowledge and Data Management   Click Here
Table 24 - Small Company Concerns Click Here
Table 25 - Use of Public and Proprietary Databases when Characterizing
Host Cell Proteins with Mass Spectrometry
Click Here 
Table 26 - Oligonucleotide Therapeutics and mRNA Click Here 
Table 27 - Control Strategies for Personalized Medicines  Click Here
Table 28 - Disposable Technologies Click Here
Table 29 - Multi-Attribute Methods Click Here
Table 30 - The Voyage of the BLA Click Here
Table 31 - How do you Define Ranges for Specifications and Comparability for
Glycosylation Attributes in the Midst of Micro-heterogeneity?
Not Available 
Table 32 - Viral Clearance and the Use of Advanced Technologies Such as NGS
in the Detection of Adventitious Agents in Biologics
Click Here
Table 33 - New Product Introduction (NPI) Strategies at CMOs Click Here 
Table 34 - Legacy Products and the Implementation of QbD Click Here 
Table 35 - Analytical Challenges Related to Antibody Drug Conjugates
Characterization and Specifications
Click Here
Table 36 - Validation of Rapid Microbiology Methods Not Available
Table 37 - Updating Compendial Methods and Biosimilars Not Available 
Table 38 - How to Characterize Polyclonal Products for Infectious Diseases Click Here 





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